Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed with Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®

Lindenhof Group

Status: Enrolling

Conditions: Degenerative Disc Disease; Spondylolisthesis; Spondylosis

Treatments: Other: ViviGen®; Other: rhBMP-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05238740

2021-02219

Details and patient eligibility

About

The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5

Full description

The investigator hypothesize that

• The bony fusion rate on a 12-month CT scan (or earlier at 6-month CT scan) is less than 10% lower in the intervention group compared to the bony fusion rate in the control group

For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who have an indication for a monosegmental ALIF procedure on the L5/S1 segment or a monosegmental XLIF procedure on L4/5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain

• Patients must be 18 - 70 years of age
• Patients must have understood and signed the study information and the informed consent form
• Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the Informed Consent

Exclusion criteria

• Patients under 18 years and over 70 years of age
• Patients with tumour / spine trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves
• Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery
• Current smokingPregnant or breastfeeding patients
• Insufficient language skills in German
• Inability to give informed consent
• Refusal to participate in the study, unsigned study consent
• Participation in another interventional study within the 30 days preceding and during the present study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Intervention group 5-5.4 cc ViviGen®

Active Comparator group

Description:

Biological: 5-5.4 cc ViviGen® The ALIF or XLIF fusion patients assigned to this group will receive 5-5.4 cc ViviGen®

Treatment:

Other: ViviGen®

Control group 4-6mg rhBMP-2

Active Comparator group

Description:

Biological: 4-6mg rhBMP-2 The ALIF or XLIF fusion patients assigned to this group will receive 4-6mg rhBMP-2

Treatment:

Other: rhBMP-2